FDA Issues Internal Regulatory Procedures Manual on Import/Enforcement Procedures, Etc.
The Food and Drug Administration has released a new version of its Regulatory Procedures Manual, a reference manual for FDA personnel containing information on internal procedures to be used in processing domestic and import regulatory and enforcement matters.
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While the manual is intended to provide guidance to FDA inspectors, investigators, and compliance officers, it can be a useful tool for the public as well.
(The FDA states that this manual does not create or confer any rights for or on any person and does not operate to bind FDA or the public. The 2008 Regulatory Procedures Manual supersedes the version printed in March 2006.)
Procedures Covered in Manual
Among other things, the manual contains internal FDA procedures on commissioning and work sharing, advisory actions, administrative actions, judicial actions, recall procedures, emergency procedures, and import operations and actions. The online version of the manual (see link below) also contains a search function.
Import Operations and Actions
Topics covered in the import operations and actions chapter of the manual include:
Import Procedures (entries, sampling, procedures when violation is found, export of merchandise refused admission, bond action, etc.)
Coverage of Personal Importations
Importation of Biological Products
FDA National Import Procedure Regarding Warehouse Entries
Release Notices
Detention without Physical Examination (DWPE)
Notice of Detention and Hearing
Response (Hearing) to Notice of Detention and Hearing
Notice of Refusal of Admission
Reconditioning
Supervisory Charges
Bond Actions
Import Information Directives
Priority Enforcement Strategy for Problem Importers
Import For Export
Importations for Trade Shows/Fairs, Exhibits and Special Events
Secured Storage (Temporary Removal Due to Pending Revision)
Communication Concerning Assessment of Civil Monetary Penalties by CBP in cases involving Imported Food
Notice of Sampling
Granting and Denying Transportation and Exportation (T&E) Entries
(The FDA states that the chapter on import operations and actions is currently under revision and notes that editorial revisions were made in January 2008.)
FDA Regulatory Procedures Manual (dated March 2008) available at http://www.fda.gov/ora/compliance_ref/rpm/default.htm